Asr medical records received.After review of medical records patient was revised to addressed metallosis.Corrosion was noted on the trunnion.The cup was removed without difficulty and came out with minimal bone.Some areas where the porous coating had been eroded by the presence of some retained stainless steel hardware from internal fixation of the acetabulum.Doi: (b)(6) 2006, dor: (b)(6) 2019, right hip.
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Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed, and the investigation will be re-opened as necessary.Device history lot : the product investigation found no evidence suspecting an error in the material, manufacturing, inspection or sterile processing that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.
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